Clinical Trial: Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation
Brief Summary:
RATIONALE: Captopril may protect the lungs from the side effects of bone marrow or stem cell transplantation.
PURPOSE: Randomized phase III trial to determine the effectiveness of captopril to lessen the side effects in patients who are undergoing bone marrow or stem cell transplantation following chemotherapy and radiation therapy.
Detailed Summary:
OBJECTIVES: I. Determine if captopril can block or prevent lung injury in patients undergoing autologous bone marrow or stem cell transplantation following cyclophosphamide and total body radiotherapy or high dose chemotherapy. II. Determine a series of surrogate lung injury prediction markers for monitoring patients undergoing therapy.
OUTLINE: This is a randomized study. Patients are stratified according to preparative regimen (high dose chemotherapy versus cyclophosphamide and total body radiotherapy). Patients are randomized into one of two treatment arms. All patients undergo a conditioning regimen consisting of cyclophosphamide daily on days -6 and -5 and total body radiotherapy on day -4 through -1, or high dose chemotherapy per transplantation protocol. Arm I: Patients receive oral captopril 2 to 3 times daily beginning on the first day of the conditioning regimen and continuing until day 100 post autologous bone marrow or stem cell transplantation. Arm II: Patients receive no captopril while undergoing conditioning therapy. Patients are followed at 6 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Sponsor: Northwestern University
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Northwestern University
Dates:
Date Received: January 28, 2000
Date Started: October 1999
Date Completion:
Last Updated: May 31, 2012
Last Verified: May 2012
